Last Updated: May 2, 2026

Details for New Drug Application (NDA): 065139

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NDA 065139 describes CLINDAMYCIN PHOSPHATE, which is a drug marketed by Glenmark Pharms Ltd, Padagis Israel, Taro, Fougera Pharms, Alembic, Amneal, Aurobindo Pharma Ltd, Encube, Solaris Pharma Corp, Sun Pharma Canada, Zydus Lifesciences, Abraxis Pharm, Almaject, Bedford, Bristol Myers Squibb, Fresenius Kabi Usa, Hikma, Igi Labs Inc, Loch, Marsam Pharms Llc, Rising, Sagent Pharms Inc, Solopak, Teva Parenteral, Watson Labs, Boca Pharma Llc, Chartwell Rx, Encube Ethicals, Fougera Pharms Inc, G And W Labs Inc, Ingenus Pharms Llc, Padagis Us, Pai Holdings Pharm, Ph Health, Taro Pharm Inds, Vintage Pharms, Xttrium Labs Inc, Carnegie, Epic Pharma Llc, Actavis Labs Ut Inc, Glenmark Speclt, Mylan Pharms Inc, Zydus Pharms, Actavis Mid Atlantic, Baxter Hlthcare Corp, Sandoz Inc, Abbott Labs, and Baxter Hlthcare, and is included in ninety-two NDAs. It is available from twenty-seven suppliers. Additional details are available on the CLINDAMYCIN PHOSPHATE profile page.

The generic ingredient in CLINDAMYCIN PHOSPHATE is clindamycin phosphate; tretinoin. There are fifty-five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.

Summary for 065139

Tradename:	CLINDAMYCIN PHOSPHATE
Applicant:	Fougera Pharms
Ingredient:	clindamycin phosphate
Patents:	0

Pharmacology for NDA: 065139

Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

Suppliers and Packaging for NDA: 065139

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLINDAMYCIN PHOSPHATE	clindamycin phosphate	CREAM;VAGINAL	065139	ANDA	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	0168-0277	0168-0277-40	40 g in 1 TUBE, WITH APPLICATOR (0168-0277-40)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;VAGINAL			Strength	EQ 2% BASE
Approval Date:	Dec 27, 2004	TE:	AB	RLD:	No

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